3 1 Foreword and Introduction As part of the "securpharm" project framework, to develop and pilot a system to implement the requirements of the European Directive 2011/62/EU to protect against counterfeiting of drugs for the German associations of pharmaceutical, manufacturers, wholesalers and pharmacists (Stakeholders), the need arose to transform the German reimbursement number (PZN), as defined in social legislation, into a globally unique product number. In this context, the "Informationsstelle für Arzneispezialitäten GmbH (IFA)" [ (German Information Center for Medicinal Products) which manages the allocation of PZN, has acquired the status of an Issuing Agency and has created a coding system (IFA Coding System). Pro Generika e.v. (Association of Generic Medical Manufacturers) Verband Forschender Arzneimittelhersteller e.v. (vfa) (Association of Research-Based Pharmaceutical Companies) Figure 1 illustrates a typical packing cascade, starting with the single component (for example, a blister pack or a bottle) through to the transport pallet. For both stages of retail packaging and transport units, IFA has corresponding coding specifications, referred to as IFA Coding System. 2 Scope While securpharm system focused on drug packaging to meet the specific legislative requirements, IFA Coding System extended the securpharm system firstly to cover all common pharmacy products (eg food supplements). Secondly, it covers the identification of: This document is the specification for the identification of transport units for logistical purposes, ie. for shipping containers, shipping pallets and possibly bundle packaging (see arrows in Figure 1) - Retail packages and - transport units. This specification has been prepared on behalf of the associations represented by IFA: ABDA - Bundesvereinigung Deutscher Apothekerverbände (German Federal Association of Pharmacists) Bundesverband der Arzneimittel-Hersteller e.v. (BAH) (German Medicines Manufacturers` Association) Bundesverband der Pharmazeutischen Industrie e.v. (BPI) (German Pharmaceutical Industry Association) Figure 1: Packing cascade (as in ISO/DTS ) Bundesverband des Pharmazeutischen Großhandels PHAGRO e.v. (Association of Pharmaceutical Wholesalers) All contents copyright securpharm e.v. English V 1.00 Page 3

4 The retail packaging specification is available under or directly at: Code_Handelspackung_IFA_Spec_EN.pdf. This document specifies the elements of a shipping label according to the European Standard EN 1573 (Bar coding - Multi-industry transport label) and the International Standard ISO (packaging bar code and two-dimensional symbols for shipping, transport and receiving labels) providing the sender, transporter and receiver unambiguous information and at the same time allowing an automated process. If all other data e.g. the return address and the recipient s address are present in the databases and available in the EDI data exchange, then the license plate is the only mandatory prescribed barcode. If the License Plate provides no link to the databases of the sender and the receiver, then these relationships must be made through additional data in the shipping label (see Extended Shipping Label section 3.3). 3.3 Extended Shipping Label If the data in the Basic Shipping Label is insufficient then the Extended Shipping Label should be used. The details of the marking and identification of the shipping units are based on the rules of transportation companies. This information is essential to allow tracking of transport units within the logistic chain. This specification does not address the relative assignment of the packaging units themselves (parent-child relationship), which is required in aggregation. For this application refer to the standard "ANSI MH10.8.2; Section VI". In addition to the License Plate (refer to Section 4.2), the Basic Shipping Label can carry the following additional encoded data: Transporter notes (e.g. Transport regulations) Shipper s address Receiver s adress Information relating to content (e.g. product number, batch details, size or weight details) 3 Shipping Label Information on data content and structures can be found in Section 4 and the symbology in Section General As a shipping label either the Basic Shipping Label or the Extended Shipping Label should be used. The Basic Shipping Label includes necessary logistics information for the sender, transporter and receiver. The Extended Shipping Label contains optional additional information. 3.2 Basic Shipping Label The Basic Shipping label contains a unique identification of the transport unit. This identification is called "License Plate" (see Section 4.2). The structure is based upon the ISO registration procedures and the relevant underlying international standards (see Appendix B 1, 2 and 3). All contents copyright securpharm e.v. English V 1.00 Page 4

5 4 Data content and requirements 4.1 General In order that the data can be interpreted unambiguously in data carriers they are to marked with Data Identifier (DI). The necessary DI are defined in the international data structure standard ISO / IEC (relating to ANSI MH10.8.2; Data Identifier and Application Identifier Standard) Creation using the IAC of the IFA The creation of a License Plate using the IAC of the IFA on the basis of the above rules is illustrated below: License Plate PP nnn...n In this chapter, the applicable Data Identifier (DI) is described and the respective associated data contents. IAC CIN Transportnumber 4.2 License Plate General Rules To provide globally unique identification, the License Plate is generated based on ISO / IEC This is a unique identification number for each transport unit. The following character blocks are arranged without separation (structure see Figure 2). License Plate xx nnn...n nnn...n IAC CIN Transportnumber Figure 3: Structure of a License Plate using the IAC of the IFA 1. The assigned Issuing Agency Code (IAC) "PP" of the IFA as Issuing Agency is used as the License Plate prefix. 2. This is followed by the IFA assigned account number (also termed "supplier number") in the form of five-digit Company_ID. This is part of the IFA Information Services (attribute "B00ADRNR"; Field Description: "Address number."), including related address and contact information. The IFA clients may request their supplier number at the following address: 3. In the third position, the number assigned by the company to the license plate. The company is responsible for ensuring the allocation of a unique number. Figure 2: Basic structure of License Plate 1. In the first position is the Issuing Agency Code (IAC). This code is specific to the Issuing Agency (IA) as assigned by the Dutch Standards Institute (NEN) on behalf of ISO. The total length of the license plate must have no more than 20 characters. This means that the shipment number may have up to 13 alphanumeric characters. License Plate using the IFA s IAC, refer to Chapter 5.3 Example The second position is the identification (Company Identification Number - CIN) of the company creating the License Plate. If license plate creation is contracted out then the client's CIN should be used. The CIN is assigned by the IA. 3. The third position is the company s uniquely generated shipment number. All contents copyright securpharm e.v. English V 1.00 Page 5

6 4.3 Data Identifier License Plate Alternative: Data Identifier: "J" Data Identifier (DI) for the License Plate are according to the standard ANSI MH (reference from ISO / IEC 15418) assigned to the the Data Identifier of group "J". The ISO / IEC allows the use of the DI J and 1J to 6J. In the standard application, the Data Identifier "J" should be used. The License Plate is formed as per Section Example: DI Data J PP When it is required to differenciate between various levels of packaging (carton, pallet, container), this may be achieved using the Data Identifier 1J to 6J. 4.4 Data Identifier "Ship to" This Data Identifier designates the recipient s address according to a standard agreed upon between logistic partners. Usually this is a combination of country code plus postal code plus additional address information. The Data Identifier DI "2L" is used for this combination is specified in ANSI MH An alternative of the recipient address can be formed through the combination of the Issuing Agency Code (IAC) from the IFA and the Company_ID of the recipient. Data Identifier - DI "25L" used is per the standard ANSI MH DI Daa 25L PP12345 "PP" is the IAC of IFA. "12345" stands for the IFA-assigned Company_ID (Customer/Supplier Number) IFA. The complete address details are available from the IFA Information Services. IFA Clients can request their Company_ID by to: 4.5 Additional data elements In the case of the Extended Shipping Label where more data elements are required, they are to be agreed upon between the logistics partners. Data Identifiers should be used as per ANSI MH and applied as appropriate. For hierarchical structured and EDI-compatible data content in 2D-code, the use of "PapierEDI" is recommended. (Source: Specification Paper EDI: Example: DI 2L Data DE All contents copyright securpharm e.v. English V 1.00 Page 6

7 5 Marking with Code und Clear text Example Symbology The License Plate can be coded in Code 128 or in Code 39. Code 128 in accordance with ISO/IEC is usually used. In the Extended Shipping Label, information additional to the License Plate can be presented in 2D Codes. License Plate according to DHL-Spezifikation (Source: Barcode- Spezifikation DHL Paket V 2.2_15. März 2012) We recommend using the Data Matrix code according to ISO / IEC in the 06 Format as per ISO / IEC Example Further Definitions The code sizes result from the selected module size (bar width) and the data contained in the code. All sizes and shapes allowed within the specified standards may be used. The specifications for code size, quiet zone (light zone), positioning, clear text information and label sizes can be found in ISO In addition, the requirements of the transport service must be observed. ShipTo Code (above) and License Plate (below) Symbology used in the examples: Code 128 according to ISO/IEC Code Examples Example 1 License Plate with IFA IAC "PP" and Company IdentificationCode "21435" (equivalent to IFA Customer Number/Supplier Number) followed by the transport number "T987368X9" All contents copyright securpharm e.v. English V 1.00 Page 7

8 5.4 Print Quality Essential for code usability is, that it can be read reliably and that the content complies with the established rules. The practical readability depends on the scanner and the operating and ambient conditions. To ensure the overall readability of a code requires a minimum print quality, defined according to a standard methodology. The classification of print quality is carried out using the table according to ISO/IEC and The current technical standards for the determination of print quality are the international standards ISO /IEC for 2D matrix codes and ISO / IEC for Barcodes. ISO/IEC- Grades ANSIlevel With repeated testing Meaning 4 A Very good 3 B Good 2 C Satisfactory 1 D Adequate 0 F less than 0.5 Failed Figure 4: Quality grades according to ISO/IEC and The print quality should meet the requirements of ISO and the needs of the transport services. All contents copyright securpharm e.v. English V 1.00 Page 8

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